Site & scope
Current authorisations and certificates, dosage-form fit and manufacturing-site allocation.
QUALITY · GMP · TECHNICAL REVIEW
Quality documentation for your decision
Assess the site, dosage form and project against a controlled quality package.
A two-site GMP manufacturing platform
Our two-site operating model connects development and manufacturing under the applicable quality framework. QA provides the current manufacturing authorisations, GMP certificates, national appendices and relevant scope documents for partner qualification.
Site 1 documentation update · 9 September 2026
Production-capability authorisation: EOF protocol 5986 / 11 June 2026. According to the company’s communication with EOF, the GMP certificate has been prepared; English copies of the certificate, authorisation and national appendix were requested on 9 September 2026. Contact QA for the issued certificate and its exact scope.
A practical qualification package
Technical readiness
Specifications, analytical methods, transfer plan, stability strategy and agreed validation responsibilities.
Quality agreement
Change control, deviations, batch documentation, complaints, release responsibilities and communication routes.
Formulated Without
Our ingredient-screening policy supports selected formulation briefs. Exclusions are applied according to product category, compatibility and client requirements; they do not imply that every excluded ingredient is unsafe or that one policy applies to every medicine.
Explore the ingredient policy